FDA Inspection
KBL GmbHKBL GmbH – FDA Inspection, May 17, 2019
Record Details
This FDA Inspection record concerns KBL GmbH, with an inspection on May 17, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · b4e1b4e2-2cac-4c13-b623-86ad8f11eaa2
Inspection Facts
- Inspection number
- 1090616
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1010.3(a)(1)ID label lacks name and address
- 21 CFR 1040.20(d)(1)(i)Label - Warning statement
- 21 CFR 1040.20(e)(1)(i)Reproduction of labels
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
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Other FDA inspections of KBL GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 2, 2016 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for KBL GmbH
- FDA Inspection 1210373 - 2023-06-15
- FDA Inspection 986138 - 2016-09-02
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